Status Report & Workshop
2023-09-18
The R Validation Hub is a collaboration to support the adoption of R within a biopharmaceutical regulatory setting (pharmaR.org)
Comparing Analysis Method Implementations in Software
A cross-industry group formed of members from PHUSE, PSI, and ASA.
| Methods | R | SAS | Comparison | |
|---|---|---|---|---|
| Summary Statistics | Rounding | R |
SAS |
R vs SAS |
| Summary Statistics | R |
SAS |
R vs SAS |
|
| … | … | … | … | … |
Works with and provides support to the R Foundation and to the key organizations developing, maintaining, distributing and using R software
Guidance on compliant use of R and management of packages
Building a public, validation-ready resource for R packages
Coline Zeballos
Connecting validation experts across the industry
Juliane Manitz
{riskmetric}Gather and report on risk heuristics to support validation decision-making
Eric Milliman
{riskassessment}A web interface to {riskmetric}, supporting review, annotation and cataloging of decisions
Aaron Clark
Keep your hand raised if…
{riskmetric}, {riskassessment})If nothing else, take this home!
.R files through their eSUB portal1.If nothing else, take this home!
Identifying Intended Use 1
Software is used directly for the production and quality systems’ automation inspection, testing, or the collection and processing of production data. Software supports development, monitoring and automated testing. A manufacturer should use a risk-based analysis to determine appropriate assurance activities.
If nothing else, take this home!
Determining the Appropriate Assurance Activities1
Assurance can include Ad-hoc testing, Exploratory testing (active package use), Error-guessing (regression testing), Robust scripted testing and Limited scripted testing (traceable, reproducible testing suites).
“This approach may apply scripted testing for high-risk features”
{riskmetric}{riskassessment}Supporting a transparent, open, dynamic, cross-industry approach of establishing and maintaining a repository of R packages.
If it’s not broke, don’t fix it!
Fool me twice, shame on me
Closing the CRAN gap for the Pharma Use Case